2nd Shift Quality Technician

Come join our growing team at Aphena Pharma Solutions !!!

Essential Functions 

• Inspect incoming components, in-process product, and finished product according to documented specifications. 

• Review all documents prior to the start of production and complete first piece approval (FPA) as required. 

• Record data and maintain accurate records in accordance with GMP good documentation practices 

• Prepare inspection sheets and other needed forms using Microsoft Word or Microsoft Excel. 

• Troubleshoot quality concerns that may arise on the production floor 

• Review all paperwork, including device/drug history records (DHR), daily for accuracy and completeness 

• Verify the calibration of all inspection test equipment and maintain accurate records. 

• Gather data and investigate relative to customer complaints. 

• Participate in the execution and documentation of process validations 

• Assist in maintaining the quality management system to be in compliance with the current ISO standard and applicable FDA GMP Regulations. 

• Perform data entry and retrieval using the Aphena computer system 

• May be required, as needed, to work overtime, weekends or alternate shifts. 

• Perform pre-approval inspections and maintain accurate records. 

• Assist in the generation and resolution of corrective and preventive action plans (CAPAs) 

• Assist in the documentation and resolution of nonconforming material reports and process discrepancy reports. 

• Generate controlled labels as needed using programs provided. Document same using proper approval forms and paperwork to issue and return materials from the Label Control Area. 

• If necessary, initiate non-conforming or process discrepancy documentation including data entry and labeling requirements. Also responsible for stock segregation if necessary. 

• Assist in material flows required to maintain label control operations including consolidation, relocation, and other practices. 

• Maintain work area orderliness and cleanliness. 

• Inspect incoming, in-process and finished product. 

Qualifications 

• High school graduate required. 

• Advanced college level courses, preferred. 

• Previous experience working with GMP Regulations pertaining to medical devices or pharmaceuticals. 

• Superior written and verbal communication skills required to communicate issues and procedures among multiple departments. 

• Competent with Microsoft Excel, Word and the Internet. 

• Ability to solve complex, multi-layered problems. 

Salary : $18 - $22